FDA.report

510(k) K910863

Device
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
Applicant
VASCUTEK LTD.
510(k) number
K910863
Product code
DSY  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-01
Date received
1991-03-01
Regulation
870.3450
Classification name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ROSHAN MAINI
Address
Newmains Ave. Inchinnan Renfrewshire Pa49rr Scotland GB

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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